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Completed

NCT Number: NCT01710904

A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain

This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.

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Key information

Conditions

Chronic Severe Pain Chemically-Induced Disorders Chronic Pain Constipation Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Induced Constipation Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brussels

Brussels, Belgium

About this study

Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients included are patients who

  • are eligible for Targinact® treatment according to the Targinact® SPC AND
  • who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND
  • who are constipated (BFI > 30) AND
  • have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment

Exclusion criteria

are based on Targinact® SPC.

Treatment and study plan

Targinact® (oxycodone/naloxone)

Drug

Primary outcomes

  1. Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.

    Time frame: 12 weeks

    A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit.

Secondary outcomes

  1. To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)

    Time frame: 12 weeks

    To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)

  2. To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)

    Time frame: 12 weeks

    To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)

  3. To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)

    Time frame: 12 weeks

    To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)

  4. To assess safety of Targinact® treatment (by physician)

    Time frame: 12 weeks

    Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.

Sponsors and collaborators

Lead sponsor

Mundipharma CVA

Other

Registry information

Official study title

The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study.

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 19, 2012
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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